Meal Composition for Healthy Habits and Diet

Overseen By Hollie Raynor, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: The University of Tennessee, Knoxville

Must not be taking: Appetite suppressants

Disqualifiers: Binge eating, Allergies, Smoking, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 5

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore how different types of foods, specifically low-energy-density (low-ED) and high-energy-density (high-ED) foods, influence eating habits and weight loss. Participants will try meals with varying amounts of low-ED and high-ED foods to determine if consuming more low-ED foods naturally leads to eating fewer high-ED foods. Healthy adults who regularly eat breakfast before 10 a.m., enjoy a variety of common foods like chicken soup and yogurt, and have no major dietary restrictions may be a good fit for this study. As an unphased trial, this study offers participants the chance to contribute to valuable research on dietary habits and weight management.

Will I have to stop taking my current medications?

The trial excludes participants who are taking medications that affect appetite, so you may need to stop such medications to participate.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that eating a healthy diet with low-calorie foods can improve overall health and help prevent diseases like diabetes. Early results suggest that meals with a variety of these low-calorie foods are linked to better nutrition and lower obesity rates.

The study examines how low-calorie and high-calorie foods affect each other when combined in different meals. The aim is to determine if eating more low-calorie foods naturally leads to consuming fewer high-calorie foods, and vice versa.

Although specific safety data from past studies on this type of meal-based research is lacking, a healthy diet is generally safe. Strong evidence indicates that eating patterns focused on low-calorie foods are both beneficial and safe. Participants in the trial can expect a safe experience when trying these meal variations. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the "Meal Composition for Healthy Habits and Diet" trial because it explores how the order in which meals are consumed can impact diet and health habits. Unlike standard dietary guidelines that focus on what to eat, this approach examines meal sequence as a factor in promoting healthier eating patterns. By experimenting with different sequences, such as starting with a protein-rich meal or a fiber-rich meal, researchers hope to uncover how meal order can influence metabolism, satiety, and long-term dietary habits. This innovative approach could lead to more personalized and effective dietary strategies for maintaining a healthy lifestyle.

What evidence suggests that this trial's treatments could be effective for weight loss?

This trial will compare different meal orders to evaluate their impact on healthy eating habits and diet. Research has shown that consuming low-calorie foods aids in weight loss by providing satiety without excessive calories. Studies also suggest that meal planning is associated with a healthier diet and reduced obesity. One study found that eating healthy meals helps individuals adhere to diet goals, supporting better weight management over time. By consuming more low-calorie foods, individuals can reduce total calorie intake while still feeling full, facilitating weight loss and a healthy lifestyle. ^{1 2 5 6 7}

Who Is on the Research Team?

Hollie Raynor, PhD

Principal Investigator

University of Tennessee

Are You a Good Fit for This Trial?

This study is for healthy adults aged 18-35 with a BMI of 18.5 to 24.9 who enjoy a variety of foods like soup, pudding, and snacks, eat breakfast before 10 am, are not on appetite-affecting meds or have eating-related medical conditions, and can finish the sessions in under 8 weeks.

Inclusion Criteria

I can attend all sessions within 8 weeks after the screening.

You need to rate all of these foods and snacks as at least 50mm on a scale to be eligible: chicken or tomato soup, chocolate sugar-free pudding, grapes, blueberry yogurt, macaroni and cheese, vanilla ice cream, pretzels, and honey graham snacks.

Body mass index (BMI) 18.5 to 24.9 kg/m2

Exclusion Criteria

You have allergies to the foods being tested in the study.

I am on medication that changes my appetite.

You have a medical condition that affects your ability to eat.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 session (60 minutes)

1 visit (in-person)

Meal Sessions

Participants attend 4 meal sessions to evaluate energy intake and food liking

2 weeks

4 visits (in-person)

Follow-up

Participants are monitored for any changes in eating behavior and overall satisfaction

1 week

What Are the Treatments Tested in This Trial?

Interventions

• Order 1
• Order 2
• Order 3
• Order 4

Trial Overview The trial tests if low-energy-density (low-ED) foods can replace high-energy-density (high-ED) ones in meals to help with weight loss. Participants will eat meals with varying ED levels over four sessions to see how their food intake adjusts.

How Is the Trial Designed?

Group I: Order 4 Experimental Treatment 1 Intervention

Meal 4, Meal 1, Meal 2, Meal 3

Group II: Order 3 Experimental Treatment 1 Intervention

Meal 3, Meal 4, Meal 1, Meal 2

Group III: Order 2 Experimental Treatment 1 Intervention

Meal 2, Meal 3, Meal 4, Meal 1

Group IV: Order 1 Experimental Treatment 1 Intervention

Meal 1, Meal 2, Meal 3, Meal 4

Who Is Running the Clinical Trial?

The University of Tennessee, Knoxville

Lead Sponsor

Trials

93

Recruited

19,500+

Published Research Related to This Trial

Dietary counseling, with or without oral nutrition supplementation, does not significantly reduce 30-day mortality in hospitalized malnourished adults but may slightly reduce 6-month mortality and complications, based on a meta-analysis of 16 studies.

The evidence suggests that dietary counseling can improve nutrition status and may reduce hospital readmission rates, although the certainty of these findings varies and further research is needed to standardize counseling methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of dietary counseling with or without nutrition supplementation in hospitalized patients who are malnourished or at risk of malnutrition: A systematic review and meta-analysis. Wong, A., Huang, Y., Sowa, PM., et al.[2022]

The novel FoodforCare meal service significantly improved protein and energy intake among patients compared to the traditional meal service, with notable increases in intake on both the first and fourth days of full oral intake.

Patient satisfaction with the meal service remained stable, but the FoodforCare group reported better satisfaction regarding the appearance and smell of the meals, indicating a positive reception of the new service.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[A novel in-hospital meal service improves protein and energy intake]. Dijxhoorn, DN., van den Berg, MGA., Drenth, JPH., et al.[2018]

In a study of hospitalized patients at nutrition risk, combining a protein-enriched menu with individualized dietary counseling led to 92% of patients meeting over 75% of their energy requirements, compared to 76% in the historical intervention group.

The intervention group also showed a significant increase in mean energy and protein intake, with 31 kcal/kg and 1.2 g protein/kg, respectively, indicating that this combined approach is more effective than using a protein-enriched menu alone.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

From Evidence to Clinical Practice: Positive Effect of Implementing a Protein-Enriched Hospital Menu in Conjunction With Individualized Dietary Counseling. Munk, T., Bruun, N., Nielsen, MA., et al.[2018]

Implementing a co-designed mealtime assistance process in a 31-bed ward led to a significant reduction in wasted meals from an average of 3 per day to 0, which also decreased food waste by 0.43 kg per patient daily.

Patients who received mealtime assistance showed no new incidences of aspiration pneumonia or swallowing difficulties, indicating that the intervention not only improved meal access but also enhanced patient safety and nutritional outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reducing risk of development or exacerbation of nutritional deficits by optimizing patient access to mealtime assistance. Teeling, SP., Coetzee, H., Phillips, M., et al.[2020]

The Korea Food & Drug Administration (KFDA) established an adverse event (AE) monitoring system for dietary supplements, collecting 1430 AE reports from 2006 to 2008, with 222 providing complete case details for analysis.

The monitoring identified a potential signal linking dietary fiber to vomiting, but due to insufficient data, the KFDA could not confirm a causal relationship, indicating the need for further investigation into this concern.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The state of adverse event reporting and signal generation of dietary supplements in Korea. Park, KS., Kwon, O.[2010]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5288891/

Meal planning is associated with food variety, diet quality and ... Meal planning was associated with a healthier diet and less obesity. Although no causality can be inferred from the reported associations.

2. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2825747

Meal Timing and Anthropometric and Metabolic Outcomes This systematic review and meta-analysis evaluates the association between meal timing strategies and anthropometric and metabolic outcomes.

3. sciencedirect.com sciencedirect.com/science/article/pii/S0195666321006668

Healthy eating strategies: Individually different or context- ... The current study aims to investigate both individual differences and contextual differences regarding the openness to different healthy eating strategies.

4. odphp.health.gov odphp.health.gov/healthypeople/priority-areas/social-determinants-health/literature-summaries/access-foods-support-healthy-dietary-patterns

Access to Foods That Support Healthy Dietary Patterns A healthy dietary pattern is associated with beneficial outcomes for all-cause mortality, cardiovascular disease, overweight and obesity, type 2 diabetes, bone ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9032066/

Food as medicine? Exploring the impact of providing healthy ... Providing medically-tailored meals significantly increases dietary adherence above 90% and allows patients to realize significantly better chronic disease ...

6. who.int who.int/news-room/fact-sheets/detail/healthy-diet

Healthy diet A healthy diet helps to protect against malnutrition in all its forms, as well as noncommunicable diseases (NCDs), including diabetes, ...

7. fns.usda.gov fns.usda.gov/cnpp/healthy-eating-index-hei

Healthy Eating Index (HEI) The Healthy Eating Index (HEI) is a measure of diet quality used to assess how well a set of foods aligns with key recommendations and dietary patterns